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| Pragmatická klinická štúdia fázy II× | Randomizovaná klinická štúdia (RKS)× | |
|---|---|---|
| Odbor | Epidemiológia | Epidemiológia |
| Rodina | Process / pipeline | Process / pipeline |
| Rok vzniku≠ | Pragmatic framework: 1967; Phase II application: 1990s–2000s | 1948 (first rigorously conducted RCT — MRC streptomycin trial) |
| Tvorca≠ | Conceptual basis: Daniel Schwartz & Joseph Lellouch (pragmatic vs. explanatory distinction, 1967); applied to Phase II context by drug developers and trialists from the 1990s onward | Austin Bradford Hill; MRC Streptomycin Trial team |
| Typ≠ | Interventional study design | Interventional experimental study |
| Pôvodný zdroj≠ | Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648. DOI ↗ | Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385 |
| Ďalšie názvy | pragmatic Phase II trial, real-world Phase II trial, Phase II pragmatic RCT, Phase IIb pragmatic trial | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial |
| Príbuzné | 6 | 6 |
| Zhrnutie≠ | A pragmatic Phase II clinical trial is an early-to-mid-stage interventional study that evaluates a new treatment's preliminary efficacy and safety under conditions that approximate real-world clinical practice rather than tightly controlled experimental settings. It sits between pure explanatory Phase II trials and large pragmatic Phase III confirmatory trials, prioritising practical feasibility and clinical relevance while still generating the signal needed to justify further development. | A randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions. |
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